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These highlights do not include all the information needed to use OPSYNVI safely and effectively. See full prescribing information for OPSYNVI. OPSYNVI ®(macitentan and tadalafil) tablets, for oral use Initial U.S. Approval: 2024
Medication labelWhy this: Advisory · dailymed-prescription
OPSYNVI is the combination of macitentan and tadalafil indicated for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II–III). Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability [see Clinical Studies (14.1)] .
- generic_name
- macitentan and tadalafil
- product_names
- macitentan and tadalafil
- ndc
- 66215-812, 66215-814, 66215-814-30, 66215-814-01, 66215-814-10, 66215-812-07, 66215-812-30, 66215-812-01, 66215-812-08
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en